Tractana 28 coated tablets - supplement for rest

Product Description

Traditional herbal medicine indicated for the relief of mild symptoms of mental stress, such as nervousness, anxiety, or irritability, and for promoting sleep.

Indications

Tractana Coated Tablets is a traditional herbal medicine used for specific indications based exclusively on long-standing use.
Tractana is indicated for adults and children over 12 years of age.

Composition

Active ingredients

Each coated tablet contains 200 mg of dry extract of Passiflora incarnata L., herba (equivalent to 700 mg - 1000 mg of passionflower).
Extraction solvent: Ethanol 60% V/V.
Excipient with known effect: Each tablet contains less than 1 mmol (23 mg) sodium, i.e. essentially "sodium-free".

Excipients

Tablet core: Microcrystalline cellulose, Povidone, Sodium starch glycolate (type A), Hydrogenated cottonseed oil, Colloidal anhydrous silica, Tricalcium phosphate. Coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc, Red iron oxide (E172). Excipient in the extract: maltodextrin.

Directions for use and Dosage

Adults and children over 12 years: - For the relief of transient mental stress: 1-2 tablets morning and evening. The dosage can be adjusted according to the individual patient's needs. The dose may be increased as directed by your doctor or pharmacist (up to a maximum of 8 tablets per day).
To aid sleep: 1-2 tablets in the evening half an hour before going to sleep.
Paediatric population: In the absence of sufficient data, use in children under 12 years of age is not recommended.
Duration of use: If symptoms persist for more than 2 weeks while using the medicine, consult a doctor or qualified healthcare professional.
Method of administration: Oral use.
Swallow the tablets with plenty of water.

Warnings

Use in children under 12 years of age has not been validated due to the absence of adequate data. If symptoms worsen while using the medicine, consult a doctor or qualified healthcare professional.
This medicinal product contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially sodium-free.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Interactions

Concomitant use of synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor or pharmacist.
To avoid drug interactions, patients should inform their doctor or pharmacist of any other treatments they are undergoing while taking Tractana.

Side effects

None known. In case of adverse reactions, consult a doctor or qualified healthcare professional. Reporting suspected adverse reactions.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

No cases of overdose have been reported.

Pregnancy and breastfeeding

Pregnancy and breastfeeding: The absence of risks during pregnancy or breastfeeding has not been established. One study in one animal species has shown reproductive toxicity (see section 5.3). In the absence of sufficient data, use during pregnancy or breastfeeding is not recommended.
Fertility: No data on fertility are available.

Storage

This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.

Format

28 coated tablets